Optimum Thiamine Intervention (OpT In) for Treatment and Prevention of Wernicke-Korsakoff Syndrome (WKS): A Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Standardised Cognitive assessment - RUDAS
研究概览
简要总结
Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be common in people with nutritional deficiencies or alcohol dependence. The primary cause of WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may lead to significant, long-term brain dysfunction with severe effects on work, personal and social function. Whilst effective treatment may greatly reduce severe disability and the human and social costs of this illness, almost no evidence exists on optimal dosing regimens. This project proposes to develop quality evidence for effective treatment of WKS in an Aboriginal setting.
详细描述
Wernicke-Korsakoff syndrome (WKS), once thought to be a rare condition, is now known to be common in people with nutritional deficiencies or alcohol dependence. The primary cause of WKS is thiamine deficiency, and more than 90% of cases are reported in alcohol dependent patients because alcohol dependence predisposes to severe nutritional deficiency. WKS may lead to significant, long-term brain dysfunction with severe effects on work, personal and social function. Whilst effective treatment may greatly reduce severe disability and the human and social costs of this illness, almost no evidence exists on optimal dosing regimens. This project proposes to develop quality evidence for effective treatment of WKS in an Aboriginal setting..
The need for evidence-based thiamine treatment protocols is of great clinical importance for two related reasons. First, in relation to acute symptomatic WKS, a failure to treat immediately or adequately may result in profound and often permanent cognitive and neurological disability. Secondly, the need for evidence-based treatment guidelines is greatly magnified when it is recognised that milder, subclinical WKS may be preventable with adequate thiamine treatment.
The aims of this study are to determine the optimal thiamine dose required for:
A. Treatment of acute symptomatic WKS among Aboriginal and non-Aboriginal alcohol dependent patients.
B. Reducing or preventing subclinical WKS-related brain damage in at-risk Aboriginal and non-Aboriginal alcohol-dependent patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged range 18-65 years
- •History of heavy alcohol use AUDIT-C score >4 or consumption >60mg/day or >80mg/binge
排除标准
- •Pregnant women
- •Under the age of 18 or over 65 years old
- •Known pre-existing neurological or cognitive impairment unrelated to thiamine deficiency or WKS
- •Renal dialysis patients
- •Sedated patients in ICU
研究组 & 干预措施
Acute Symptomatic WKS- 300mg
Thiamine Hydrochloride 300mg daily (i.e. 100mg 3 times/day) for 5 days
干预措施: Thiamine Hydrochloride (Drug)
Acute Symptomatic WKS - 900mg
Thiamine Hydrochloride 900mg daily (i.e. 300mg 3 times/day) for 5 days
干预措施: Thiamine Hydrochloride (Drug)
Acute Symptomatic WKS - 1500mg
Thiamine Hydrochloride 1500mg daily (i.e. 500mg 3 times/day) for 5 days.
干预措施: Thiamine Hydrochloride (Drug)
High-risk subclinical WKS- 100mg
Thiamine Hydrochloride 100mg once daily for 3 days.
干预措施: Thiamine Hydrochloride (Drug)
High-risk subclinical WKS- 300mg
Thiamine Hydrochloride 300mg (i.e. 100mg 3 time/day) for 3 days
干预措施: Thiamine Hydrochloride (Drug)
High-risk subclinical WKS - 900mg
Thiamine Hydrochloride 900mg daily (i.e. 300mg 3 times/day) for 3 days.
干预措施: Thiamine Hydrochloride (Drug)
结局指标
主要结局
Standardised Cognitive assessment - RUDAS
时间窗: Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using Standardised cognitive assessment - Rowland Universal Dementia Assessment Scale (RUDAS).
Standardised Cognitive assessment - CogState
时间窗: Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using CogState battery.
Standardised Cognitive assessment - Story Memory Recall Test
时间窗: Days 1 and 5 for Acute symptomatic patients and Days 1 and 3 for at risk patients
Evaluate differences in cognitive outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days); and among patients at high risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); using Story Memory Recall test
Standardised neurological examination
时间窗: Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients
Evaluate differences in neurological outcomes among acute symptomatic WKS patients under three parenteral thiamine treatment conditions (300mg/day for 5 days, versus 900mg/day for 5 days, versus 1500mg/day for 5 days);and among patients at high-risk of subclinical WKS-related brain damage under three parenteral thiamine treatment conditions (100mg/day for 3 days, versus 300mg/day for 3 days, versus 900mg/day for 3 days); Using Standardised neurological examination. Aggregated as either normal or abnormal.
次要结局
- Readmission(Day 1)
- Blood thiamine levels(Days 1 and 5 for acute symptomatic patients; days 1 and 3 for at risk patients)
- Magnesium levels(Days 1 and 5 for acute symptomatic patients; Days 1 and 3 for at risk patients)
- Demographic factors(Day 1)